I.To evaluate the anti-inflammatory and immunomodulatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy in patients with advanced NSCLC.II.To evaluate symptoms and quality-of-life outcomes, the incidence of grade 3-4 toxicities, dose reductions, dose delays, and completion of scheduled carboplatin and docetaxel chemotherapy with SL Anvirzel in patients with advanced NSCLC.Entry Criteria

Disease Characteristics:

•Patients must have histologically or cytologically confirmed diagnosed non-small cell lung cancer (NSCLC) and be scheduled to receive four courses of carboplatin and docetaxel chemotherapyScheduled to begin carboplatin and docetaxel chemotherapy in the next 30 days

•Newly diagnosed or previously treated patient with NSCLC; previously treated patients are allowed to have any previous chemotherapy for the treatment of NSCLC

Prior/Concurrent Therapy:

•See Disease Characteristics•No patients receiving any other investigational agents•Patients receiving any medications or substances that are inhibitors or inducers of CYP 3A4 are ineligible•No patients using or scheduled to use bevacizumab during study period•No current use of cardiac glycoside

Primary Outcome(s)MTD of SL dosing of Anvirzel in combination with chemotherapy Pharmacokinetics of carboplatin and docetaxel when administered concurrently with SL Anvirzel

Secondary Outcome(s)Anti-inflammatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapyImmunomodulatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapySymptoms and quality-of-life outcomes based on MDASI-LC and SF-12 scoresGrade 3-4 toxicities at each course according to NCI CTCAE version 4.0Dose reduction and delays at each course

Outline

This is a dose-escalation study of oleandrin (nerium oleander extract).

Patients receive oleandrin sublingually (SL) 3 times daily (TID) on days -7 to 0 of course 1 and then throughout each course of carboplatin IV and docetaxel IV. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients complete the MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) and the quality-of-life (SF-12) questionnaires at baseline and periodically during treatment.

Plasma and peripheral blood mononuclear cell samples are collected at baseline and periodically during treatment for biomarker, pharmacokinetic, and pharmacodynamic studies.

After completion of study treatment, patients are followed up for 4 weeks.

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